Less than a week after announcing 3 new guidance documents to streamline the review of digital health, the FDA is moving to refine its 510(k) medical device approval pathway.
Gene therapy has freed 10 men from nearly all symptoms of hemophilia for a year so far, in a study that fuels hopes that a one-time treatment can give long-lasting help and perhaps even cure the blood disease.
Alexion Pharmaceuticals, Inc. (ALXN) and Halozyme Therapeutics, Inc. (HALO) announced a collaboration and license agreement that enables Alexion to use Halozyme’s ENHANZE® drug-delivery technology in the development of subcutaneous formulations for their portfolio of products. The agreement provides Alexion with the opportunity for exclusive development of up to four targets, including a next generation subcutaneous formulation of ALXN1210 (ALXN1210 SC), the company’s investigational long-acting C5 complement inhibitor, to potentially further extend the dosing interval of ALXN1210 SC to once every two weeks or once per month.
The Philippines has suspended the sale and distribution of Sanofi’s dengue vaccine, authorities said on Tuesday, after the French pharmaceutical giant last week warned it could worsen symptoms for people who had not previously been infected.
A UK trial study has found that type 2 diabetes could potentially be reversed through weight loss, and with the long-term support of a medical professional.
Health2Sync, a Taiwan-headquartered company that offers a diabetes tracking service, has closed a $6 million Series B round aimed at expanding its business in Japan and other markets in Asia.
Stratasys, one of the big 3D printing companies, has announced the release of its new BioMimics line of 3D printed human anatomy models. The products are designed to be used in clinical training and to help design and test new medical devices.
Shares of Sage Therapeutics have shot up more than 75 percent this morning after the company announced positive topline results for its Phase II treatment for patients with moderate to severe major depressive disorder (MDD).
Carmot Therapeutics, (Berkeley, CA) announced that it has entered into a multi-year drug discovery collaboration and licensing agreement with Amgen (Thousand Oaks, CA). As part of the agreement, Carmot will apply its proprietary lead-identification technology, Chemotype Evolution, to discover and advance novel drug leads intended for the treatment of Parkinson’s disease and other selected disease areas.
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